Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia (BEST-CLI)

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This study will compare the effectiveness of best available surgical treatment with best available endovascular treatment in adults with critical limb ischemia (CLI) who are eligible for both treatment options.

Male and female subjects aged 18 years or older will be randomized to receive either open surgical treatment or endovascular treatment. They will be followed for at least 2 years and up to 4 years and 2 months after treatment to primarily assess survival and major adverse limb events in the index or treated limb, and secondarily, to determine clinical and cost effectiveness outcomes after treatment. These outcomes (survival-free of major limb events and clinical, functional and cost effectiveness) will be compared within two cohorts of subjects: those with an available single-segment great saphenous vein, and those with an alternative conduit. The null hypotheses for both cohorts is that there will be no difference in MALE-free survival between best endovascular therapy and best surgical therapy.

Time to major adverse limb event or death, whichever occurs first in subjects with Single-Segment Great Saphenous Vein (SSGSV) available [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 50 months per subject ]

Time to major adverse limb event or death, whichever occurs first in subjects without available SSGSV [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 50 months per subject ]

Secondary Outcome Measures
:

Time to re-intervention of the index leg, amputation of the index leg, or death, whichever occurs first in subjects with SSGSV available [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 50 months per subject ]

Time to re-intervention of the index leg, amputation of the index leg, or death, whichever occurs first in subjects without available SSGSV [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 50 months per subject ]

Number of re-interventions in the index leg in subjects with SSGSV available [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 50 months per subject ]

Number of re-interventions in the index leg in subjects without available SSGSV [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 50 months per subject ]

Time to all-cause mortality in subjects with SSGSV available [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 50 months per subject ]

Time to all-cause mortality in subjects without available SSGSV [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 50 months per subject ]

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Candidate for both endovascular and open infrainguinal revascularization as judged by the treating investigators

Adequate aortoiliac inflow.

Adequate popliteal, tibial or pedal revascularization target defined as an infrainguinal arterial segment distal to the area of stenosis/occlusion which can support a distal anastomosis of a surgical bypass.

Any prior index limb infrainguinal stenting or stent grafting associated with significant restenosis within 1 cm of stent or stent-graft, unless the occlusion/restenosis site is outside the intended treatment zone (i.e.,. a tibial vessel that is not currently intended to be revascularized as a part of the treatment for CLI).

Any of the following procedures performed on the index limb within 3 months prior to enrollment: